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Hepatitis B clinical trials

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NCT ID: NCT03495570 Not yet recruiting - Chronic Hepatitis C Clinical Trials

Sysmex-XN 20 Analyser to Assess Lymphocyte Subsets and Other Haematological Parameters in Chronic/Acute Viral Infections

SASA
Start date: April 15, 2018
Phase:
Study type: Observational

The XN-20, is a full blood count (FBC) analyser with an extended differential counting and flagging System. The XN-Series' individual channels allow real-time reflex analysis, and uses a two stage process to classify the white blood count (WBC) sub-populations and detect the presence of abnormal reactive and malignant cells. In regards to lymphocytes in the peripheral blood, the machine has the capacity to distinguish activated from non-activated T-cell subsets using a very small volume of EDTA sample (88uL) (including remnant sample from a standard full blood count) with results available in 1.5 minutes. It is a fully automated process and can be considered as an alternative rapid flow cytometry method. Objective of the SASA study: to investigate the signal pattern of white blood cells assessed using the XN-20 full blood count platform in patients with untreated viral infections i.e. HIV, HCV and HBV. The data from the analysis will be reviewed in conjunction with patient's demographic and clinical disease characteristics with the aim of detecting characteristic cell populations that can be used in the development of system flags for future studies.

NCT ID: NCT03362866 Not yet recruiting - Hepatitis C Clinical Trials

Epidemiology of Hepatitis B, C and Delta in Reunion Island

HEPEPID
Start date: January 2019
Phase:
Study type: Observational

Viral hepatitis B, C and Δ represent a global public health problem for which France was very early mobilized. Despite this, in its foreword, the Dhumeaux report on "Management of people infected with hepatitis B or hepatitis C viruses" identifies a residual area of weakness in this care that is the incomplete regional epidemiological data in the Overseas Territories. The specific ethno-socio-cultural characteristics of these territories make it difficult to transpose data from the mainland France. This study aims at improving our knowledge on the characteristics of patients with hepatitis B, C and Δ in Reunion Island, their follow-up, their evolution and complications.

NCT ID: NCT03349008 Not yet recruiting - Chronic Hepatitis b Clinical Trials

Magnesium Isoglycyrrhizinate Followed by Diammonium Glycyrrhizinate and Combined With Entecavir in Chronic Hepatitis B

MAGIC-101
Start date: November 25, 2017
Phase: Phase 4
Study type: Interventional

This study evaluates the addition of glycyrrhizin to entecavir in the treatment of patients with chronic hepatitis B in China. Half of participants will receive magnesium isoglycyrrhizinate followed by oral diammonium glycyrrhizinate and entecavir in combination, while the other half will receive a placebo and entecavir.

NCT ID: NCT03341195 Not yet recruiting - Tuberculosis Clinical Trials

Mobile Phone SMS Messages and Automated Calls in Improving Vaccine Coverage Among Children in Pakistan

Start date: January 2018
Phase: N/A
Study type: Interventional

Routine childhood immunization (RCI) in Pakistan is well below the recommended coverage of 90% with rates as low as 16% in certain regions (Pakistan DHS 2012-3). This has led to continued polio transmission, large measles outbreaks and thousands of deaths from vaccine-preventable diseases (Kazi.Bull WHO 2016). Mobile phone communication is widespread in developing countries and has proven a potential method of directly connecting pregnant women and mothers to health services (Kharbanda. Expert Review of Vaccine 2014). The investigators propose conducting a mixed methods proof of concept cluster randomized trial (CRT) to assess the effectiveness of different types of SMS messaging and automated calls to improve RCI and understand the perceptions and barriers that may affect SMS and automated call-based interventions at participants levels. the investigators will conduct the study at urban and rural sites in Pakistan. The investigators will examine an important public health question - do low cost, automated SMS, and automated messages improve RCI coverage in resource-constrained settings? Further, investigators will compare the effectiveness of reminder, educational and interactive text messages for improving RCI and will generate socio-cultural data regarding the impact of participants health beliefs that will be important for setting up the appropriate interventions in other LMICs.

NCT ID: NCT03308890 Not yet recruiting - Chronic Hepatitis B Clinical Trials

The Effect of Entecavir Consolidation on Post-TDF Treatment Durability

Start date: November 1, 2017
Phase: Phase 4
Study type: Interventional

Clinical relapse occurred much earlier and tended to be more severe after cessation of TDF than ETV. The follow-up interval and intensity would be different between ETV and TDF after discontinuation of therapy. Whether switch therapy from TDF to ETV can modify the pattern of relapse is interesting but unclear. Our hypothesis is that entecavir consolidation on post-TDF treatment patients reduce and delay the clinical relapse effectively. Hence in this proof of concept study we would like to evaluate the effect of 6 months and 12 months of entecavir consolidation on post-TDF treatment durability.

NCT ID: NCT03167229 Not yet recruiting - Hepatitis B Clinical Trials

TDF Medicine to Prevent Mother to Child Transmission of Hepatitis B

TDF
Start date: June 1, 2018
Phase: Phase 4
Study type: Interventional

Our goal is to determine the viral kinetics of HBV DNA reduction in 170 non-Thai pregnant women receiving Tenofovir disoproxil fumarate (TDF) to inform a subsequent RCT. The investigators also aim to determine adherence to daily TDF in pregnancy as new interventions must not only be effective but also safe, feasible and acceptable in the local, and ideally global, context. Study Design: One arm, open label, Tenofovir treatment intervention study Study Participants: Non-Thai pregnant women estimated gestation 12-20 weeks and their offspring Planned Sample Size: 170 Primary Objective To estimate the time to HBV DNA suppression (<100 IU/ml) in 170 HBV DNA positive women who start TDF late in the first or early in the second trimester. Outcome Measures Time in months to HBV DNA < 100 IU/ml Secondary Objectives 1. To estimate the proportion of women with HBV DNA <100 IU/ml at delivery. 2. To estimate the TDF levels at delivery in women who are HBV DNA detectable and undetectable. 3. To monitor safety of TDF in the Thailand-Myanmar border women 4. To address potential barriers to implementing TDF in early pregnancy to PMTCT-HBV. 5. To determine the rate of hepatic flares post-partum. 6. To estimate the proportion of cases of vertical transmission at 2 months of age. 7. Fetal growth monthly ultrasound, infant growth at 1,2,3,6,12 and neurodevelopment at 6 and 12 months

NCT ID: NCT03113058 Not yet recruiting - Clinical trials for Adoptive Treatment for Hepatitis B With ?dT Cells

"Treatment of Active HBV With γδT Cells" Clinical Trial Protocol

Start date: May 2, 2017
Phase: Early Phase 1
Study type: Interventional

To evaluate the safety and anti-HBV efficacy of γδT cells.

NCT ID: NCT03038802 Not yet recruiting - Chronic Hepatitis b Clinical Trials

A Randomised Controlled Phase 1 Study of Vaccine Therapy for Control or Cure of Chronic Hepatitis B Virus Infection

HBV003
Start date: September 30, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

This is a pilot study to determine the safety and efficacy of a novel adjuvanted hepatitis B virus (HBV) vaccine formulated as a potential therapeutic vaccine against chronic HBV infection. An ongoing human clinical trial of this HBV vaccine in a prophylactic setting has confirmed this vaccine to be more effective at inducing seroconversion as measured by development of Hepatitis B surface antibody (HBsAb) in poor responder subjects than the standard alum-adjuvanted HBV vaccine, providing promise that this new vaccine may also be able to induce HBV viral control and/or seroconversion in chronically infected subjects

NCT ID: NCT02808299 Not yet recruiting - Liver Injury Clinical Trials

Liver Injury by Statins in Patients With History of Hepatitis B Virus Infection

LISHBV
Start date: December 2016
Phase: N/A
Study type: Observational

The purpose of this study is to investigate the incidence of liver injury by statins in coronary heart disease (CHD) patients with history of hepatitis B virus (HBV) infection.

NCT ID: NCT02793791 Not yet recruiting - Chronic Hepatitis B Clinical Trials

Prophylactic Treatment of Hepatic Dysplastic Nodules in HBsAg Positive Patients

Start date: September 2016
Phase: N/A
Study type: Interventional

The aim of this study is to determine that for hepatic dysplastic nodules in patients with chronic hepatitis B, instead of enhanced follow-up, whether early minimally-invasive ablation therapy can reduce the incidence of hepatocellular carcinoma.